GLINT is a multi-centre, randomised, double-blind, parallel group, pragmatic, primary prevention trial comparing the effect of extended-release metformin with placebo on a macrovascular composite cardiovascular outcome in people with non-diabetic hyperglycaemia (NDH) (HbA1c 5.5 to 6.49%) and high CVD risk (≥20%) in primary care. The Unit leads a 30 month feasibility study set in Cambridge and Leicester, in collaboration with the Diabetes Trials Unit in Oxford; 500 participants will be recruited in the feasibility phase (330 via the Unit and 170 via our collaborating site in Leicester). This is to test the practicalities of the various aspects of the trial to confirm its feasibility. If proven, we will apply for funding for a large-scale trial recruiting an additional 12,398 eligible individuals from a further six geographical regions in the UK to demonstrate the effectiveness and cost-effectiveness of metformin in preventing cardiovascular events over five years in people with NDH. Follow-up of participants will continue until 1046 adjudicated events have occurred (approximate median of five years) which enables detection of a 17% reduction in the relative risk of a CVD event with 85% power and 95% confidence. Results from GLINT will inform national primary prevention strategies for type 2 diabetes and CVD, and provide the strongest evidence to date that metformin may have a role in cancer prevention.
Recruitment for the feasibility phase of GLINT is complete.
NIHR Health Technology Assessment grant held by Unit for 30 month feasibility study.